Manager, Regional Regulatory Affairs – Cross-Regional Operations and Strategy Support

Johnson & Johnson

Manager, Regional Regulatory Affairs supporting Innovative Medicine at Johnson & Johnson. Collaborating on regulatory strategies for global healthcare innovation and product development.

Posted 7/16/2026full-timeRaritan • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Regulatory Affairs, particularly in pharmaceutical regulatory processes, with a strong focus on drug development and submission strategies. Proven ability to lead cross-functional teams and manage multiple projects effectively in a global and multi-cultural environment.

Highest-signal resume keywords

Regulatory Affairs ExperiencePharmaceutical Regulatory ExperienceProject Management SkillsGlobal Regulatory Affairs ExposureCommunication and Interpersonal Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PlansRegistration Dossier PreparationDrug Development PhasesRegulatory Strategy ImplementationInspection and Audit SupportDossier Re-Use StrategiesProduct RegistrationRegulatory Input for Product ComplaintsTactical ImplementationHealth Authority Liaison

Soft Skills

Analytical SkillsOrganizational SkillsInterpersonal SkillsAbility to Work in a Multi-Cultural EnvironmentFlexibility in Working Hours

Certifications & Qualifications

Bachelor’s Degree in Scientific DisciplineMaster’s Degree in Scientific DisciplinePharmDPh.D.

Industry Keywords

Regulatory StrategyPharmaceutical IndustryAsia PacificLatin AmericaEMEADrug DevelopmentCommercialized ProductsProduct ObjectivesRegional Working GroupsMulti-Phase Drug Development

About the role

Key responsibilities & impact

Implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
Represent the regions and contribute to the regional and global regulatory strategy through participation in product-related teams.
Advise product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
Lead the Regional Working groups to ensure timely execution of product objectives and align regional deliverables with those of the global teams.
Facilitate tactical implementation at the regional level and ensure ongoing and effective communications with the regional and global teams on product activities and issues.
Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
Liaise directly with Local operating companies as needed and assist in the preparation for meetings with regulatory agencies in the regions.
Oversee management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
Development of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, including submission plans and preparation submission documents.
Preparation of registration dossiers and dossier re-use strategies.

Requirements

What you’ll need

A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
A minimum of 6 years of relevant regulatory experience (3 years in pharmaceutical regulatory) with a Bachelor’s degree;
A minimum of 4 years of relevant regulatory experience (2 years in pharmaceutical regulatory) with a Master’s or PharmD degree;
A minimum of 2 years of relevant regulatory experience (1 year in pharmaceutical regulatory) with a Ph.D. degree is required.
Broad Regulatory Affairs experience across drug development and commercialized products, including experience in a therapeutic area and multiple phases of drug development, is required.
Global Regulatory Affairs exposure/experience is required.
Pharmaceutical Regulatory Affairs experience in at least one major geographic region is preferred.
Experience in Asia Pacific, Latin America and EMEA countries is preferred.
Demonstrated project management skills required.
Experience in working/leading project teams is required.
Demonstrated ability to independently handle multiple projects is required.
Must have excellent communication and interpersonal skills.
Must have strong analytical and organizational skills.
The ability to work and thrive in a multi-cultural and matrix environment is required.
The ability to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones is required.
This position may require up to 10% travel.

Benefits

Comp & perks

Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year